Iso 13485 standard
These solutions include multiple functionalities, such as non-conformity management or risk assessment and management.
Iso 13485 standard software#
We implement software that makes it easier for you to obtain international ISO 13485 certification, including our EDM solution and our tools to manage and improve your workflow. ISO 13485:2016 specifies requirements for a quality management system of an organization that needs to demonstrate its ability to provide medical devices and related services and consistently meet customer and applicable regulatory requirements. The latest version of ISO 13485, in 2016, focuses particularly on risk assessment. Risk analysis, throughout the design and development of products, is also a major subject of the standard.
the monitoring of possible incidents when medical devices are put into operation or incidents that may result from the use of medical devices once they are on the market. This standard also deals with the organization of material vigilance, i.e. The standard is thus intended for distributors, subcontractors, suppliers, manufacturers, repairers and maintenance agents of medical devices.Īs the health sector is undoubtedly one of the most regulated in the world, one of the objectives of ISO 13485 is to set up processes to facilitate compliance with regulatory requirements and ensure maximum product traceability. Within this sector, health risks are high and the regulations in force are particularly abundant - ISO 13485:2016 is an independent standard for quality management for medical devices, and is based globally on the ISO 9001 standard.įacilitate the understanding of regulations A medical device is therefore generally used to diagnose, prevent or even treat diseases. The medical devices concerned by ISO 13485 are machines, products, implants, instruments or reagents used in vitro, i. This is an internationally recognised standard that sets a high level of requirements for your quality management system. Specific approach for validating software.ISO 13485 standard ISO 13485:2016 is a standard for the medical devices sector.
Iso 13485 standard verification#
This standard was conceived to help medical. ISO 13485:2016 is an international standard that establishes the requirements for a quality management system specific to the medical devices industry.